FDA 510(k)

CASSI II Rotational Core Biopsy System

Número K: K161234 · 2016-08-03

RequerenteScion Medical Technologies, LLC

Data da decisão2016-08-03

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CASSI II Rotational Core Biopsy System is the device name listed in this FDA 510(k) record. The listed applicant is Scion Medical Technologies, LLC. It received FDA 510(k) clearance on 2016-08-03 under 510(k) number K161234. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CASSI II Rotational Core Biopsy System?

CASSI II Rotational Core Biopsy System is a medical device that received FDA 510(k) clearance on 2016-08-03. The listed applicant is Scion Medical Technologies, LLC. The 510(k) number is K161234.

When did CASSI II Rotational Core Biopsy System receive FDA 510(k) clearance?

CASSI II Rotational Core Biopsy System received FDA 510(k) clearance on 2016-08-03, under 510(k) number K161234.

Who is the listed applicant for CASSI II Rotational Core Biopsy System?

The FDA 510(k) record lists Scion Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CASSI II Rotational Core Biopsy System?

The FDA product code for CASSI II Rotational Core Biopsy System is KNW.

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